Methods for injecting a curable biomaterial into an intervertebral space

ABSTRACT

A method for treating a diseased or damaged spinal disc having an inner nucleus pulposus and an outer annulus is provided comprises the steps of: providing access to the nucleus pulposus through the annulus; removing at least a portion of the nucleus pulposus to create an intradiscal space; determining the integrity of the annulus; and then sealably introducing under pressure a curable biomaterial through the annulus access directly into the intradiscal space. The step of determining the integrity of the annulus may be accomplished by introducing into the disc a fluid solution under a first pressure. The curable biomaterial may subsequently be introduced through the annulus directly into said intradiscal space at a second pressure that is increased or decreased from the first pressure as a function of the viscosity of the biomaterial relative to the fluid solution. In certain embodiments, a distraction force is applied to the disc space.

REFERENCE TO RELATED APPLICATION

The present application claims priority to co-pending provisionalapplication No. 60/583,665, entitled “SYSTEMS AND METHODS FOR INJECTINGA CURABLE BIOMATERIAL INTO AN INTERVERTEBRAL SPACE”, filed on Jun. 29,2004, the entire disclosure of which is incorporated herein byreference.

BACKGROUND OF THE INVENTION

The present invention relates to systems and methods for the treatmentof the spine, and especially the interbody disc space. Morespecifically, the invention concerns the injection of a biomaterial intoa spinal space, such as the intradiscal space.

Spine fusion procedures represent the state of the art treatment forintervertebral disc problems, which generally involve open surgery andthe use of interbody fusion cages and spinal fixation systems tostabilize the fusion site. An alternative treatment under evaluation isto replace or augment the disc or nucleus pulposus with a prostheticdevice. Examples of some devices currently under investigation includein-situ cured polymers such as polyurethanes and protein polymers, whichmay have properties varying from a rubbery hydrogel to a rigid plastic.Problems associated with these devices occur during insertion, wherebythe pressure required to fill the disc space can cause leakage of thematerial into sensitive adjacent areas.

A number of devices are available for distracting vertebral bodies orfor injecting material into the disc. Some devices are capable of bothdistraction and injection using the same instrument. These types ofdevices use a deflated balloon attached to a cannula and insertedbetween the vertebral bodies. The balloon is inflated with a prostheticfluid through the cannula to distract the vertebral bodies. Thisrequires high-pressure delivery of the fluid to achieve the pressureneeded to distract the vertebral bodies and the balloon and fluidpermanently remain in the disc space. Alternatively, a separate deviceis used to inject the prosthetic fluid around the balloon and theballoon is used strictly for distraction after which it is deflated andremoved.

U.S. Pat. No. 4,772,287 (“Ray I”) discloses a bladder injected withthixotropic gel implanted between two vertebral bodies to restore thedisc height. The technique described requires that the vertebral bodiesare first distracted and a bore drilled to allow for insertion of thebladder.

U.S. Pat. No. 5,562,736 (“Ray II”) discloses a method for implanting aprosthetic disc nucleus. Ray II discloses cutting a first and secondflap in the annulus. The flaps provide access to the nucleus. Ray IIthen discloses using an inflatable jack to distract the disc space priorto insertion of the prosthetic spinal disc nucleus. The jack has adeflated balloon on its end that is inserted into the nucleus throughone of the flaps. The balloon is inflated with fluid causing thevertebral bodies to distract. Once the vertebral bodies are sufficientlydistracted the fluid flow is stopped and the prosthetic spinal discnucleus is inserted through the other flap. The balloon is then deflatedand the second prosthetic spinal disc nucleus is inserted. The flaps areclosed and placed in contact with the annulus by a suture, staple orglue.

U.S. Pat. No. 6,187,048 (“Milner”) discloses an implant for anintervertebral disc nucleus pulposus prosthesis made from a conformable,in-situ curable, material which is resiliently deformable. Milnerdiscloses removing the nucleus material, then either injecting throughthe annulus or creating an opening in the annulus to deliver a curablematerial under pressure into the nucleus space. The pressure isnecessary to ensure conformation to the nucleus space and/or to increasethe internal pressure of the disc space to distract the vertebralbodies. The amount of pressure needed to distract the disc space is highand may allow the material to flow through cracks or voids in theannulus into the disc space. Milner also describes an embodiment wherethe curable material is injected into a flexible container that isinserted first into the nucleus space in a deflated state and inflatedby the material as the material is injected. This method relies on thepressure of the fluid as it is injected to distract the vertebralbodies. Although this avoids the problem of the material leaking throughthe annulus, it imposes certain constraints such as designing a cover ofthe correct shape and size suitable for safe injection of the curablematerial and prevention of leakage of the material from the cover oncefilled.

U.S. Pat. No. 6,248,131 (“Felt”) describes distracting and injecting atthe same time using a balloon device. The balloon can be used as a shellfor containing the injected curable biomaterial and also used as adistraction means as the material is injected. Another embodimentdescribes the balloon as a cylinder shape which when inflated inside thedisc space bears against the endplates for the vertebral bodies anddistracts them. Then a second device is used to inject the curablebiomaterial around the balloon cylinder. The material is allowed to cureand then the balloon is removed and a second curable biomaterial can beinjected into the space left where the balloon was. In sum, when Feltdiscloses injecting material outside of the balloon, Felt disclosesusing a second device to carry out the injection. Insertion of thissecond device into the disc should typically require a second breach ofthe annulus fibrosus.

Much of the prior art contemplates free injection of biomaterial into aspinal space which may lead to uncontrolled leakage. The art alsodescribes injection of the material into a deflated balloon, whichrequires leaving the balloon inside the disc space. Lastly, some methodsrequire insertion under high pressure, thereby creating a potential forthe prosthetic fluid to ooze or seep out of the disc spaceintra-operatively.

There is therefore a need for a system and method for introducing abiomaterial into a spinal space that is not prone to the problems of theprior art, especially the leakage problem experienced by the highpressure injection systems. This need extends to systems that can beeasily utilized in a minimally invasive procedure.

SUMMARY OF THE INVENTION

To address these needs, a method for treating a diseased or damagedspinal disc having an inner nucleus pulposus and an outer annulus isprovided comprising the steps of: providing access to the nucleuspulposus through the annulus; removing at least a portion of the nucleuspulposus to create an intradiscal space; determining the integrity ofthe annulus; and then sealably introducing under pressure a curablebiomaterial through the annulus access directly into the intradiscalspace. The access may be provided by an extraforaminal approach to thedisc selected from the group of surgical entries consisting of a lateralretroperitoneal approach and a paramedian approach through theparaspinal muscles. The access is an opening extending through theannulus which may be through a rupture in the annulus resulting from aherniation or surgically created by an annulotomy. The annulotomy may bein a cruciate form.

The step of determining the integrity of the annulus may be accomplishedby introducing a fluid into the disc through the annulus opening and atleast into the intradiscal space. In certain embodiments, the fluid is asaline solution injected under pressure by a needle extending throughthe access opening. In accordance with certain embodiments, this stepincludes providing a seal for the annulus opening during the injectionof the saline solution. The seal may be provided on the needle andinclude a compressible portion that is pressed against he exteriorsurface of the annulus adjacent the access opening. A vent may be formedin the seal for venting the intradiscal space.

The methods of this invention may include the further step ofdetermining the approximate amount or volume of biomaterial to beintroduced. This determination may be accomplished by measuring theamount of saline solution injected into the disc. In order to ensurethat the approximated amount of biomaterial needed is as accurate aspossible, the biomaterial is sealably injected through a needle at apressure not greater than the pressure at which the saline solution isinjected.

In a further aspect of the invention, a method for treating a diseasedor damaged spinal disc having an inner nucleus pulposus and an outerannulus is provided that comprises the steps of: providing access to thenucleus pulposus through the annulus; removing at least a portion of thenucleus pulposus to create an intradiscal space; sealably introducinginto the disc through the opening a fluid solution under a firstpressure to determine the integrity of the annulus; and then sealablyintroducing under a second pressure a curable biomaterial through theannulus directly into the intradiscal space. As with the above describedmethod, the fluid solution may be a saline solution injected into thedisc through a sealed needle. In accordance with certain embodiments,the second pressure under which the biomaterial is introduced is notgreater than the first pressure under which the fluid solution isintroduced.

The methods of the present invention may be practiced in the treatmentof a herniated disc, wherein the access is defined by a rupture throughthe annulus. Alternative, the methods may be practiced in the treatmentof degenerative disc disease, wherein the access is an opening createdthrough the annulus by an annulotomy.

In yet another feature of the invention, a method for treating adiseased or damaged spinal disc between opposing vertebral bodies havingan inner nucleus pulposus and an outer annulus, comprises the steps of:providing access to the nucleus pulposus through the annulus; removingat least a portion of the nucleus pulposus to create an intradiscalspace; applying a force to distract the opposing vertebral bodies aboutthe intradiscal space; determining the integrity of the annulus, andthen sealably introducing under pressure a curable biomaterial throughthe annulus access directly into the intradiscal space. As indicatedabove, the access is an opening extending through the annulus. In oneaspect of the invention, the distraction force may be applied byinserting an inflatable device through the opening in a deflatedcondition and inflating the inflatable device within the intradiscalspace. The inflatable device may be a non-compliant balloon.

In certain embodiments, the method further includes the step ofdetermining the size of the intradiscal space. The step of determiningthe size of the intradiscal space may be practiced by expanding aninflatable device within the intradiscal space. The inflatable devicecan be a compliant balloon inserted into the intradiscal space in adeflated condition and inflated within the intradiscal space until itstops against the far border of the intradiscal space. In certainaspects, the compliant balloon is filled with a contrast medium capableof visualization under fluoroscopy.

In accordance with certain embodiments, the distraction force is removedprior to the step of introducing the biomaterial into the intradiscalspace. In some methods of the present invention, the distraction forceis applied on the vertebral bodies externally of the intradiscal space.This external distraction force may be maintained during the step ofintroducing the biomaterial into the intradiscal space.

It is one object of the present invention to provide a method forintroducing a biomaterial into an intradiscal space for the treatment ofvarious spinal disorders. Further objects are achieved by aspects of theinvention that allow for assessing the integrity of the disc annulus andaccurately determining the size of the intradiscal space to be filledwith the biomaterial. Other objects and certain benefits of theinvention will become apparent upon consideration of the followingwritten description taken together with the accompanying figures.

DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of a mixing system for mixing an injectablebiomaterial.

FIG. 2 is a pictorial view of the withdrawal of a cross-linker to beadded to the biomaterial in the mixing system shown in FIG. 1.

FIGS. 3-5 are diagrammatic view of surgical approaches to theintervertebral disc.

FIG. 6 is a pictorial view of a trial balloon assembly for use in amethod of one embodiment of the present invention.

FIG. 7 is a pictorial representation of the use of the trial balloonshown in FIG. 6 in accordance with one aspect of the invention.

FIG. 8 is a pictorial view of a distraction balloon for use in a furtheraspect of the present invention.

FIG. 9 is a pictorial representation of the distraction balloon of FIG.8 shown in situ.

FIG. 10 is a fluoroscopic view of a distraction balloon in situ.

FIG. 11 is a pictorial view of the injection of the cross-linker intothe biomaterial mixing system.

FIG. 12 is a pictorial view of the step of mixing the biomaterial withinthe mixing system.

FIG. 13 is a pictorial representation of a vented injection needleassembly in accordance with one aspect of the present invention.

FIG. 14 is a fluoroscopic view of the vented injection needle assemblyof FIG. 13 shown in situ.

FIG. 15 is a front perspective enlarged view of the vented injectionneedle in accordance with one embodiment of the invention.

FIG. 16 is an enlarged pictorial view of the vented injection needledepicted in FIG. 15 shown in situ.

FIG. 17 is an enlarged pictorial view of the distraction balloon shownin FIG. 9.

FIG. 18 is an enlarged perspective view of a seal in accordance with afurther embodiment of the invention.

FIG. 19 is a lateral pictorial view of the spine with an injectionassembly positioned to introduce a curable biomaterial into an affecteddisc in a percutaneous procedure.

FIG. 20 is an enlarged view of the disc shown in FIG. 19 with theinjection needle and docking cannula of the injection assemblypositioned within the disc annulus.

FIG. 21 is an enlarged view of a disc with a docking cannula accordingto a further embodiment with the injection needle extending therethroughinto the disc space.

FIG. 22 is an enlarged cross-sectional view of the docking cannula andinjection needle depicted in FIG. 21.

FIGS. 23 a-b are side views of a docking cannula according to a furtherembodiment of the invention that includes an expandable flange, shownwith the flange in its non-expanded and expanded positions.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and described in the following written specification. It isunderstood that no limitation to the scope of the invention is therebyintended. It is further understood that the present invention includesany alterations and modifications to the illustrated embodiments andincludes further applications of the principles of the invention aswould normally occur to one skilled in the art to which this inventionpertains.

In one embodiment of the invention, adjacent vertebral bodies aredistracted (by a non compliant balloon) at a predetermined pressure,such as at 200 psi (13 atmospheres). Using a non-compliant balloonrestricts the lateral dimension of the balloon and ensures that there isno lateral loading, or pressurization of the annulus, thereby avoidingthe risk of damaging the annulus. The balloon (and thereby thedistraction device) is then removed allowing the distracted vertebralbodies to remain distracted due to the natural stretching of thesurrounding ligaments. The distraction with the balloon under pressureis held for a period of time sufficient to stretch the ligaments and tocause the distraction to be maintained even after the balloon isremoved. This period of time will vary between patients; however, incertain procedures a period of about 20-30 seconds has been sufficient,while in other cases the period may be several minutes. While there maybe some slight contraction of the ligaments initially, the vertebralbodies will remain spaced apart at a substantially desired spacing forsome time to then enable introduction of biomaterial into the distracteddisc space.

The biomaterial is sealably introduced under pressure that is not ashigh as used for the distraction step but that is sufficient so that thebiomaterial will completely fill the space (or the partial space in apartial discectomy). Moreover, the injection pressure for thebiomaterial is sufficient to recover any small amount of contractionthat may occur when the balloon is removed. In accordance with onefeature of the invention, the injection of the biomaterial occurs underlow pressure. This pressure is nominally less than 100 psi, and inspecific embodiments is in the range of 25-40 psi. A vent is used toexhaust the disc space and allow body fluid and/or air as well asbiomaterial to seep out when the space is filled. Seepage of biomaterialindicates a complete fill of the disc space.

The low pressure on the biomaterial is held until the biomaterial iscured. This cure time is material dependent, but often falls in therange of about five minutes. Maintaining the pressure until curing alsomaintains the distracted disc space under hydrostatic pressure. Evenunder the low pressure, a seal must be provided around the opening inthe annulus through which biomaterial is introduced. The seal in onearrangement is disposed on the material injection tube and is appliedagainst the exterior surface of the annulus adjacent the opening.

In a particular procedure, a surgical technique is provided for the useof injectable disc nucleus (IDN) as a replacement for or theaugmentation of the natural nucleus pulposus. The IDN is preferably acurable biocompatible polymer with properties that emulate those of thenatural human disc. A suitable IDN material is disclosed in U.S. Pat.Nos. 6,423,333; 6,033,654; and 5,817,303, which issued to ProteinPolymer Technologies, Inc. The disclosures or these patents areincorporated herein by reference. These patents disclose a proteinaceouscurable polymer that has physical properties close to those of the humandisc nucleus pulposus and that includes certain adhesive properties thatallow the polymer to adhere to the disc annulus and any remaining discnucleus pulposus.

In a first step of the technique, a mixing system 10 is provided formixing the constituents of the IDN material, as shown in FIG. 1. Themixing system 10 may be constructed as disclosed in co-pending, commonlyassigned patent application Ser. No. 10/803,214, entitled “Systems andMethods for Mixing Fluids”. The entire disclosure of this application isincorporated herein by reference, and particularly the discussion of theembodiment shown in FIGS. 3-9 in that application. In a specificembodiment, the mixing system 10 is prepared prior to the start ofsurgery by loading the assembly with four mL of a polymer constituent.This volume is mixed with a cross-linker constituent. In the specificembodiment, the volume is mixed with 34±1 μL of crosslinker drawn from asterile vial 12 into a 100 μL syringe 14, purged of air, as shown inFIG. 2. The syringe is placed on the sterile table until it is neededfor the mixing and injection step.

Where the biomaterial is an IDN, access to the intradiscal space isrequired. While many surgical approaches may be used, in one specificembodiment, the surgeon will use an extraforaminal mini-open approach tothe disc. This may be either by a lateral retroperitoneal approach (FIG.3) or a paramedian approach (FIG. 4) through the paraspinal muscles ofthe back. Access to the nucleus is gained through an extraforaminalannulotomy, so as to not expose the spinal canal or foramen to any unduerisk. The annulus is identified and a minimal annulotomy is performed togain access to the intradiscal space. If necessary, a cruciateannulotomy of up to 5 mm×5 mm may be used. The annulotomy should beoriented obliquely with one cut oriented with the outer fibers of theannulus, as shown in FIG. 5. The nucleus pulposus is then partially orcompletely removed using known techniques, such as using pituitaryrongeurs and/or curettes. Alternatively, a mechanical method such asendoscopic shaving, hydraulic or radiofrequency (RF) technology may beused. The nucleotomy should be fully irrigated once all loose fragmentshave been manually removed.

The prepared nuclear cavity should be visualized prior to proceedingusing a compliant trial balloon assembly 20, as depicted in FIG. 6. Oncethe balloon 22 is assembled to the inflation syringe 24 and primed withan inflation medium, the balloon is inserted through the annulotomyuntil it stops against the far border of the nucleotomy space.Preferably, the inflation medium is a fluid contrast medium that can bevisualized under fluoroscopy. Injection of contrast media into theballoon and inflation under light pressure will allow the surgeon tojudge the location and size of the space (FIGS. 7 and 17). In certainembodiments, the disc space can be visualized and the inflated size ofthe trial balloon measured to determine the distracted size of the discspace. An endoscopic camera may also be used to inspect the interior ofthe nucleotomy space, if desired by the surgeon.

If further removal of nucleus pulposus is indicated, the balloon can beremoved and the nucleotomy continued. This iterative process may berepeated until the surgeon is satisfied with the size and location ofthe nucleotomy. In one feature of the invention, the final volume ofcontrast media injected into the balloon may then be used to estimatethe volume of the nucleotomy and determine the amount of IDN that willbe needed to fill the space.

Once the size of the space has been determined, the next step of thepresent invention involves distracting the space. In one embodiment,distraction of the disc is accomplished using a spherical balloon 30,such as a 15 mm diameter spherical balloon. The balloon is made of anon-compliant material and is adapted to provide a distraction forceagainst the endplates of the disc. In a specific embodiment, the balloon30 is able to be pressurized to approximately 13 atmospheres (200 psi).It is inflated using an inflation syringe 32 attached to the Luerfitting 34 on the catheter 36 of the balloon, as shown in FIG. 8.Pressure feedback is preferably obtained through tactile feel as thehandle 35 is depressed, and/or through a pressure gage 38 mounted on thebody of the inflation syringe.

When the syringe and balloon are primed with contrast media, the balloonis inserted into the disc space until it stops against the far border ofthe nucleotomy, as shown in FIG. 9, but is preferably positioned in thecenter of the disc space. The balloon is gradually inflated until itcontacts the endplates and ultimately pushes apart the endplates toachieve the desired amount of distraction (FIG. 10). By creating anucleotomy that is greater in diameter than the diameter of the balloon,the surgeon can ensure that no loading of the annulus occurs and thatthe distraction force is applied solely to the endplates. Care should betaken to ensure the pressure rating of the balloon is not exceeded andthat the endplates are not compromised by over-distraction.

Once the desired amount of distraction has been obtained, the balloon isdeflated and removed from the disc. At this point, the trial balloon 22may be used again to evaluate the resulting final nucleotomy. If thetrial balloon is re-used, the resulting fluid volume may again be usedto estimate the volume of IDN needed to the fill the distracted space.

Alternatively, distraction may be obtained using the surgeon's preferredtechnique. Other distraction techniques such as laminar distraction,screw/pin distraction, patient positioning, and traction may be used. Aspreservation of an intact endplate is important, the distractiontechnique may need to be altered from patient to patient in order toaddress this matter. One technique may be preferred over others incertain instances due to patient bone quality and anatomy. If additionaldistraction is applied, the trial balloon 22 may be used again toprovide an estimate of the requisite IDN fluid volume.

In one aspect of the procedure, the distraction of the disc space ismaintained by the patient's anatomy, rather than by a distraction devicemaintained in the disc space. It has been found that if the distractionaccomplished as described above is maintained for a certain length oftime the spinal ligaments will stretch and retain their lengthenedconfiguration for sufficient time to inject the IDN and allow it tocure. In a specific embodiment, maintaining the distraction for about 5minutes was sufficient to cause the surrounding ligaments to maintainthe distraction long enough to complete the IDN injection and curingprocess.

Immediately prior to injection, suction is applied to the cavity formedby the removal of tissue during the nucleotomy. A surgical swab may alsobe used to wick away excess moisture from the injection site. This willensure that excess fluid does not interfere with the injection of theIDN material. Once the injection site has been prepared, the surgeonwill hold the syringe assembly 10 with the crosslinker injection port 12oriented upward. The entire volume of polymer should now reside in onesyringe 14. The sterile assistant will inject the pre-measured volume ofcrosslinker from the crosslinker syringe 14 into the mixing assembly 10through the port 12, as shown in FIG. 11.

The surgeon then mixes the crosslinker and polymer by cycling theplungers of the syringes 14 and 16 back and forth a predetermined numberof cycles that is based upon the properties of the particular polymer.For the proteinaceous polymers disclosed in the Protein Polymer patentsdescribed above, the plungers are preferably cycled through 10 fullcycles in 10 seconds (FIG. 12). For these polymers, it is important tocomplete the mixing procedure in ten seconds or less in order to ensurecomplete and proper mixing of the IDN. Upon completion of the mixingstep, the surgeon disassembles the syringe 14 (no insert in the syringe)from the adapter 13. From this point, the surgeon has a fixed amount ofworking time to perform the injection using the second syringe 16. Withthe specific polymers, this working time is about 80 seconds. Anappropriate previously selected injection needle is connected to the tipof the syringe 16 and the needle is primed with the fully mixedbiomaterial composition prior to introducing the needle to the injectionsite. The initial drops from the injection needle can be ejected ontothe surgical field and used as a qualitative gage of the working time ofthe IDN during the injection procedure.

In accordance with one construction, the injection needle is provided aspart of an injection assembly 40, as shown in FIG. 13. The injectionneedle 42 extends through a seal element 46 that is configured toprovide an essentially fluid tight seal against the disc annulus A. Avent 44 also extends through the seal 46. The seal 46 is shown in moredetail in FIG. 15. In a particular form of the construction, the seal 46includes a body 48 that is preferably formed of a resilient materialthat can be compressed slightly under manual pressure to conform to theirregular external surface of the disc. The body 48 defines a sealingface 50 that bears against the disc annulus A (FIG. 13) to form thefluid tight seal.

Extending from the sealing face 50 is an engagement boss 52. The boss 52is preferably configured in accordance with the shape of the annulotomycut into the annulus. As illustrated, the annulotomy is cruciate, sothat boss 52 is also cruciate in shape. In particular, the boss 52includes wings 53 that are sized to fit within corresponding legs of thecruciate cut into the annulus A. The leading edges 53 a of the wings 53can be rounded, as shown in FIG. 15, to facilitate placement of the boss52 within the annulotomy.

The vent 44 provides an additional wing 57 for the boss 52. The wing 57includes a channel 58 that integrates with the hollow vent 44.Preferably, the vent wing 57 is co-extensive with the other wings 52.Alternatively, the working end of the wing 57 can project slightlyfarther into the disc space. The injection needle 42 feeds to a channel55 defined in the boss 52 to provide a pathway for the IDN into the disccavity.

In accordance with another aspect of the procedure, the needle isintroduced through the annulotomy, while carefully retracting the nerveroot, until the plug seal 50 seats against the annulus, as depicted inFIGS. 13-14. Preferably, the needle is positioned so that the vent 44 isfacing upward during the injection, as depicted in FIG. 16. Pressure isapplied to the seal 46 to ensure no IDN leaks out between the seal andannulus. Preferably, this pressure is applied manually by the surgeon bysimply pressing the needle catheter 42 toward the annulus. Since the IDNinjection occurs at low pressures, the amount of force required tomaintain a fluid-tight seal between the seal face 50 and the annulus isminimal.

Alternatively, the injection assembly 40 may be modified to incorporatevarious of the sealing techniques described in co-pending applicationSer. No. 10/282,755, filed on Oct. 29, 2002 in the name of inventorsBoyd et al., and assigned to the assignee of the present invention andapplication. This co-pending application, entitled “Devices and Methodsfor the Restoration of a Spinal Disc”, was published on May 1, 2003, asPub. No. U.S. 2003/0083641A1. The disclosure of this co-pending andcommonly assigned patent application and publication is incorporatedherein by reference for all purposes, and specifically the disclosure ofthe sealing and venting techniques illustrated in FIGS. 11-14 thereof.

The IDN is injected into the space until IDN is seen flowing into or outof the vent tube. In a specific embodiment, the vent tube 44 is clear sothat the presence of IDN fluid within the vent can be immediatelydetected. At this point, the injection is stopped and the needle is heldin place until the IDN takes its initial set. A microscope or loupe maybe used to visualize the injection process.

As disclosed herein, the IDN is allowed to substantially completely curebefore the injection needle assembly 40 is removed and the surgical siteis closed. The cure period depends upon the particular IDN material. Forthe specific proteinaceous polymer discussed above, the cure period is aminimum of about five minutes. If IDN material is left within theannulotomy or external to the disc, it is preferably removed usingrongeurs after the material has taken its initial set. Suction may alsobe used around the periphery of the annulotomy to remove cured material.

The volume of IDN injected into the site is preferably recorded from thegraduations on the syringe 16. The injection volume will be thedifference between the pre- and post-injection graduation readings. Thewound is closed and dressed using the surgeon's preferred technique.

As explained above, the IDN is injected under low pressure, which at aminimum means enough pressure so that the IDN will fill all the spaceleft by the excised nucleus material. The pressure should be sufficientso that the intradiscal cavity can be filled in an acceptable amount oftime, which is determined primarily by the cure rate for the IDN. In theillustrated embodiment, the working time for the IDN (i.e., the timefrom complete mixing of the constituents until the IDN has cured orhardened too much to flow) is about 80 seconds. Thus, the pressureexerted through the syringe should be sufficient to completely fill theintradiscal cavity in about on minute. Manual operation of the syringeis preferred, but it is contemplated that other forms of pressurizedinjection of the IDN into the disc space is contemplated.

The seal 46 is formed of a resilient and deformable material so that itcan be compressed against the annulus A to form a fluid tight seal. In aparticular form, the seal 40 is formed of SILASTIC® or a similarelastomeric material. The seal 46 in the illustrated embodiment iscylindrical with a circular sealing face 50; however, otherconfigurations are contemplated provided they can adequately conform tothe outer surface of the disc annulus.

In a further variation, the vent 44 can simply constitute a vent openingin the seal 46. The vent tube 44 is preferred because it carries thevented fluid away from the surgical site and can bring the dischargeopening within clear view of the surgeon. As a further alternative, theseal 46 can be separate from the injection needle 42 and vent tube 44.In other words, the channels 55 and 57 can extend through the body 48 ofthe seal 46. Catheters for the injection needle and vent can extend intothe appropriate channel, preferably with a press-fit or fluid-tightengagement.

In yet another alternative, the cruciform boss 52 can be in the form ofa duck-bill valve, as shown in FIG. 18. In particular, the seal 60includes a valve boss 62 in the form of a cruciform duckbill valve. Eachwing 63 of the boss 62 includes a slit passageway 65 that expands underfluid pressure. Thus, as fluid flows into the seal 60, the duckbillvalve wings 63 expand to allow the fluid to flow into the disc space.Moreover, this expansion of the valve boss 62 enhances the seal betweenthe cruciate boss and the annulotomy.

The procedures described heretofore are particularly well suited foropen surgical procedures where a microdiscectomy is performed to removeall or a portion of the disc nucleus. One such procedure is for thetreatment of degenerative disc disease (DDD) where a total or partialnucleotomy is indicated. In such an open procedure access to the spinaldisc is accomplished through an incision made through the skin andsubcutaneous body tissue down to the surgical site is displaced andretracted. In the case of DDD, the annulus is typically relativelyintact so that a minimal annulotomy is required to gain access to theintradiscal space. It is preferred that the opening is as small asfeasible to minimize damage to the annulus. In one embodiment, accessmay be via a K-wire over which a dilator, or a series or dilators, ispassed. However, the nucleus pulposus may be significantlyunder-hydrated or may contain significant fissures throughout thenucleus material, producing significant patient pain and giving rise tothe need for a total or substantially total discectomy.

In such a DDD procedure, in addition to the steps described hereinabove,the surgeon may also chose to perform an intraoperative step ofdetermining the integrity of the annulus, to confirm that the annulus iscompetent to withstand the distraction and IDN injection pressures. Toaccomplish this test, upon completion of the partial or total nucleotomyand creation of an intradiscal space within the disc annulus, a salinesolution may be injected into the intradiscal space through theannulotomy opening. A saline solution is preferred since it isrelatively easy to aspirate for removal from the intradiscal space.However, other suitable solutions may also be used. The saline solutionmay be injected through a vented needle, in design and constructionsimilar to the needle 40 shown in FIGS. 13-15. When the saline injectionis under relatively low pressure (on the order of 25-40 psi under thumbpressure from the syringe and pressing the seal 46 against the externalsurface of the annulus), this step evaluates the integrity of the discannulus—i.e., detects whether fissures or rents may be present in theannulus. This detection may be by tactile feel and/or by observation ofleakage only at the injection needle site.

Alternatively, or additionally, the injected saline solution may be usedto estimate the volume of the disc space to be filled with IDN material.If preferred, a trial balloon, such as the trial balloon 22 describedabove, may be used to ascertain the volume of the intradiscal space tobe filled. After the annulus integrity and volume tests have beencompleted, suction is applied to aspirate the nuclear cavity and asurgical swab may be used to wick away excess moisture that mayinterfere with the injection of the IDN material. Thereafter, thesurgeon may use the distraction balloon as illustrated in FIGS. 8-10 toapply a distraction force within the intradiscal space to distract theopposing vertebral bodies on either side of the intradiscal space,further separating apart such vertebral bodies. A subsequent saline testmay be conducted to further verify the integrity of the annulus. The IDNmay then be sealably injected under pressure using the vented needle 40as described hereinabove. Such injection of IDN is preferred to be at apressure that is not greater than the pressure under which the salinesolution is injected and is typically on the order of 25-40 psi. Whilethe saline solution has been described as preferably being injected witha vented needle such as described herein, it should be appreciated thata needle without a vent, but with a sealing element, could also be usedin the practice of the annulus integrity test.

The methods and devices of the present invention are also contemplatedfor use in performing other open surgical procedures, such as an adjunctto microdiscectomy (AMD) procedure. An AMD procedure is indicated wherea total discectomy is not required, or more particularly where only apartial discectomy is necessary to restore normal or near normalfunction to the affected disc. In a typical case, the affected disc hasa herniation or tear in the disc annulus. Access to the intradiscalspace is thus available through the tear in the annulus.

Prior to the start of the surgery, the injectable curable polymerconstituents are pre-loaded into the mixing syringe assembly, asdescribed above, and left on the sterile instrument table until theappropriate time for injection of the IDN material. The surgeon uses atraditional open or microdiscectomy technique of preference for accessto the disc herniation site. Typically, the patient will be placed on alaminectomy frame in the prone position with the spine flexed to aidintraoperative exposure. The ligamentum flavum and laminar edge areidentified. A hemilaminectomy/medial facetectomy may be performed asnecessary, with the aid of lateral fluoroscopy. Exposure of the herniaproceeds in a known manner, taking care to protect the dura and nerveroot. The epidural space is explored to ensure that all disc fragmentshave been identified.

Once the disc herniation has been identified, a determination is made asto whether a further annulotomy is needed for improved access. If so, anannulotomy may be performed as described above. The herniated disctissue is then removed according to known techniques, such as usingpituitary rongeurs and/or curettes. Laminar distraction and/or flexionof the hips can be used to aid in exposure of the hernia site. Inaddition, distraction of the affected disc may be desired to improve thestability of the disc. This distraction may be accomplished using any ofthe techniques described above. If sufficient disc tissue has beenremoved around the herniation site, the distraction balloon may be used,provided that the balloon is removed once the desired distraction hasbeen achieved.

This balloon distraction may also be supplemented in a two stagedistraction technique described as follows. After a total or partialnucleotomy has been performed, in the first stage, a distractionballoon, such as the balloon 30 described above, is inserted into theintradiscal space. The balloon is then inflated to gain distraction ofthe anterior column of the disc space.

In the second stage, a secondary distraction instrument is introduced toact on any posterior bony structures at the particular intervertebrallevel in accordance with known surgical techniques. The secondaryinstrument is used to obtain distraction of the posterior column at anappropriate amount decided by the surgeon. The nature and amount of thissecond stage distraction may increase the overall amount of distractionof the total space, change the lordotic angle at the intervertebrallevel or cause no appreciable increase in the overall distraction of thespace.

Once the appropriate amount and type of secondary distraction has beenobtained, the first stage distraction balloon is removed, while thesecondary instrument remains in place to prevent any loss of distractionthat may occur. With the distraction balloon removed, the IDN may beinjected as described above. One benefit of this two-stage distractiontechnique is that the IDN material need not be injected under pressurein order to regain any distraction loss that may occur with the singlestage distraction approaches discussed above. This benefit makes thistwo-stage approach particularly well suited for microdiscectomy inherniated nucleus pulposus cases in which the size of the opening ortear in the annulus can be widely variable. In these cases, sealing ofthe annular opening may be problematic, which ultimately makespressurization of the IDN injection difficult.

In accordance with this embodiment, the secondary distraction instrumentis preferably a laminar or interspinous instrument. A laminar distractorapplies distraction force across the superior and inferior laminararches, while the interspinous instrument applies force against thesuperior and inferior spinous processes. In either case, the secondaryinstrument does not interfere with the removal of the first stagedistraction balloon or the injection of the IDN material into thedistracted space.

After suitable distraction is achieved, a saline solution as describedabove with respect to the DDD procedure may be injected through a ventedneedle into the intradiscal space to check the integrity of the annulusand to determine that there are no other leakage paths, as well as toestimate the volume of the intradiscal space to be filled. While thisannulus integrity test is described as being conducted afterdistraction, it may also be done after removal of nucleus and prior todistraction.

When the nuclear cavity has been prepared, the surgeon mixes the IDNconstituents, as described above, to prepare the IDN material forinjection. An injection needle, which is not required to be a vented,sealed needle, is introduced through the opening in the annulus untilthe needle tip reaches the far side of the cavity. As the IDN materialis injected, the needle is preferably angled side-to-side and graduallywithdrawn toward the annulus to ensure a complete fill of the space.When the IDN material is detected at the inner border of the annulusopening, the injection is stopped and the needle is removed from thesite. Alternatively, a vented needle 40 with a seal 46 may be used, suchas where the rent through the annulus is relatively small and not tooirregular. With a vented needle 40, the injection is stopped when theIDN material is seen at the vent. It is contemplated that the IDNmaterial will be injected under pressure, typically on the order of25-40 psi, to ensure complete fill of the cavity,, with the seal 46 ofthe vented needle 40 being pressed against the annulus during IDNinjection.

The present invention also contemplates a procedure for percutaneousdirect injection of a curable biomaterial for treatment of degenerativedisc disease. As explained above, treatment for DDD is indicated wherethe disc annulus is generally intact, but the nucleus pulposus has beencompromised, either by dehydration or the creation of fissures and thepatient suffers from significant pain. In some DDD procedures, forexample, as described hereinabove, some or all of the nucleus is removedto create an intradiscal space for injection of curable biomaterial. Inaccordance with the following descriptions of the invention, thedefective or degenerated nucleus is not removed, but is insteadaugmented by a curable biomaterial or IDN material in a percutaneousprocedure.

In a percutaneous procedure as intended herein, access to the spinaldisc is achieved simply by introduction of a relatively small and sharpcannulated device, which may include a needle, through the skin and bodytissue down to the surgical site under fluoroscopy or by using otherconventional surgical navigation techniques. No incision is made nor isany body tissue retracted. Further, injection is continued by insertionof the cannulated device through the annulus into the nucleus pulposus,preferably without additional dilators and without removing any of theannulus tissue. As such, the percutaneous procedure of the presentinvention provides a minimally invasive approach to treating DDDconditions.

A first step of the procedure is preferably to obtain a pre-operativediscogram. The discogram will verify whether the annulus has sufficientintegrity and competency to contain the injected nucleus augmentation.Ordinarily, the discogram will be performed two or three days prior tothe comprehensive surgery. As explained in more detail below, since theIDN material is preferably injected at a relatively high pressure,verification of annulus integrity is desirable. The pressure of theinjected IDN is preferably at least as high as 100 psi and potentiallyas high as 200 psi so as to achieve distraction of the opposed vertebralbodies and increased disc height, desirably approaching normalanatomical conditions, upon injection of the IDN. In this discogram, thepatient may be given an epidural injection and an inflation syringe isused to inject a contrast solution directly into the disc. The inflationsyringe 32 shown in FIG. 8 may be used to introduce the pressurizedcontrast medium. For this procedure, the inflation syringe 36 ismodified to eliminate the balloon 30 mounted to the end of the catheter36, leaving the lumen of the catheter open for the contrast medium toflow through into the disc. The pressure gage 38 may be used to verifythe fluid pressure as the contrast agent is manually injected into thedisc. Preferably, the injection pressure for the contrast medium isestablished by correlating its viscosity relative to the viscosity ofthe IDN material to be injected. If the viscosity is generally the same,the injection pressure for the IDN should not be greater than thepressure of the injected contrast medium in the discogram. In a specificembodiment, the contrast medium is injected to approximately 160 psi. Ifthe contrast medium has a lesser viscosity than the IDN, the injectionpressure of the injected contrast medium may be decreased accordingly,so as to lessen the pain the patient may experience. If leakage isobserved under fluoroscopy, use of the direct injection of IDN may becontraindicated and alternative treatments may be sought, one of whichis described hereinbelow.

The discogram procedure is conducted in accordance with conventionaltechniques as shown and described, for example, in U.S. Pat. No.6,370,420, which is incorporated herein by reference. While the contrastmedium used in the discogram is fluid it is typically viscous,approximating the viscosity of the pre-cured IDN material. In addition,it has a contrast agent that allows it to be visualized underfluoroscopy or other imaging techniques, permitting a visual observationof any leakage paths or fissures in the disc annulus prior to surgery. Adiscogram is commonly done several days prior to surgery so as to allowthe contrast medium to dissipate and be absorbed into body tissue.However, an intraoperative discogram may also be considered.

As another possible intra-operative test of annulus integrity, a salinesolution as described hereinabove may be considered. While a salinesolution may be easier to remove than contrast medium, there is notsufficient contrast agent for fluoroscopic visualization or likeimaging. Leaks may be detected manually, however, by tactile sensing bythe surgeon, especially if upon injection of the saline solutionpressure fails to build and stop, with injection of saline injectioncontinuing. As such, a saline solution test may be performedintra-operatively as a final annulus integrity test as well as fordetermining the approximate volume of IDN material to inject.

In accordance with the percutaneous procedure, the IDN material isprepared in the same manner described above, with the loaded mixingassembly and crosslinker syringes made available on a sterile instrumenttable until the appropriate time for injection of the IDN material. Inparticular, the injection assembly 70 shown in FIGS. 19-20 is used toaccomplish the injection step. The assembly 70 includes a sharpcannulated device, such as a thin-walled docking cannula 72 with anintegral mating hub 76. In this particular construction, the cannula 72has an relatively smooth outer surface and substantially constant outerand inner diameters along its length. An injection needle 74 (FIG. 20)is slidably disposed within the docking cannula in a relatively closedimensional fit. The needle 74 is integral with a hub 78 that may beconfigured to mate with the hub 76 of the cannula. A stopcock valve 80is fluidly connected to the hub 78, and the injection syringe 82 isconfigured to engage the stopcock valve in any known manner effective tocreate a fluid tight connection. The injection syringe 82 may be one ofthe syringes 14, 16 of the mixing system illustrated in FIG. 1.

The patient is preferably placed in a prone position on an appropriateconventional Andrews frame or equivalent table, in the proper lordoticposture with the hips flexed to aid in the exposure of the posteriordisc. The docking cannula 72 is introduced to the disc in anextraforaminal location using a typical posterolateral discographyapproach. A guide stylet may extend through and be disposed in thecannula to assist in passing the cannula through the body tissue to thedisc annulus A. The tip of the docking cannula 72 is preferablyconfirmed, via fluoroscopy, to reside within the disc annulus, asdepicted in FIG. 20. The stylet is removed once the docking of thecannula 72 is achieved. However, it is essential that the tip of thedocking cannula break through the annulus into the nucleus pulposus toensure injection of the IDN material into the nuclear space and not intothe annulus. In this initial step of the surgical procedure, the dockingcannula 72 will be engaged in the annulus and the hub 76 supported bythe soft tissue between the disc and the entry point in the patient'sback. The docking cannula is therefor sized for percutaneousintroduction, while sufficiently large to accommodate an injectionneedle capable of injecting the IDN material. Thus, in a specificembodiment, the docking cannula may be a 16-20 hypodermic gage cannula.The cannula has a length from the tip 73 to the hub 76 that issufficient to allow the hub to sit outside the body. In a specificembodiment, the docking cannula 72 has a length of about 100 mm.

While a sharp-tipped stylet may be used in a conventional manner to aidinsertion of the docking cannula, the docking cannula 72 itself may beconfigured to puncture the disc annulus, such as by a sharpened edge atthe tip 73 of the cannula. Once the docking cannula is properly dockedwithin the annulus it forms a substantially fluid-tight interface withthe disc annulus. Since the procedure does not require an annulotomy,the elasticity of the annulus and other tissues surrounding the disccause those tissues to compress around the cannula 72 to effect a seal.In addition, the injection needle 74 is sized for a close running fitwithin the docking cannula 72. Preferably, the injection needle is nomore than two gages smaller than the docking cannula. Thus, in thespecific example, the injection needle may be 18-22 hypodermic gagecorresponding to the 16-20 hypodermic gage cannula dimension.

Once the cannula 72 has been docked within the annular wall the IDN maybe prepared as described above with reference to FIGS. 11-12. The IDNmaterial may be the proteinaceous polymer that is the subject of theProtein Polymer Technology patents discussed above. The proteinaceouspolymer in those patents is described as having a lap shear tensilestrength that within 30 minutes, usually within 15 minutes, more usuallywithin 5 minutes, will be at least 100, preferably at least about 250,more preferably at least about 300, usually not exceeding about 4000,more usually not exceeding about 3000 g/cm². This polymer isparticularly well-suited for the percutaneous DDD procedure because as aresult of its strong adhesive properties the polymer adheres to theexisting nucleus pulposus and disc annulus. It is also biocompatible andpermeable, containing about 80% water. As described in more detailbelow, the IDN material is injected under pressure into the nucleuspulposus to fill all voids, interstices and fissures that may exist inthe existing nucleus. When the polymer cures in situ, it adheres to theexisting natural disc material for essentially seamless integration withthe existing disc nucleus, thereby substantially restoring the normaldisc function. Further, since the IDN is injected directly into thenucleus within the disc space without any balloon or other physicalbarrier, there is greater potential for transporting nutrients to thecells and vertebral endplates surrounding it.

Once the IDN material has been prepared within the syringe 82, thesyringe is mated with the stopcock valve 80 of the injection needle hub78. The injection needle is then fed into the docking cannula 72 andinto the nucleus pulposus and extended approximately to the center ofthe disc. The position of the needle tip is preferably confirmed viafluoroscopic imaging. The entire IDN injection process should becompleted fairly rapidly before the IDN material cures to a viscositythat will prevent full introduction of the IDN into the entire discnucleus. In the specific embodiment using the polymer material discussedabove, the surgeon must complete the injection within about 80 secondsafter the IDN material has been fully mixed. Proper placement of thedocking cannula 72 and the mating fit between the cannula hub 76 and theinjection needle hub 78 can ensure that the needle tip is positionedsubstantially at the center of the disc, so that the fluoroscopicverification can be completed very quickly.

Once the needle tip position is verified, the syringe 82 may bemanipulated to inject the IDN material through the needle 74 and intothe disc space. Again, given the curing time constraints, the injectionmust proceed smoothly but rapidly so that all of the IDN material isinjected into the disc space under pressure. In one embodiment, the IDNmaterial is injected at a pressure in the range of about 100-160 psi,which is considered sufficient to achieve some distraction of the discto account for some disc compression that may be associated with the DDDcondition. This will provide increased stability to the disc, thustreating pain associated with DDD conditions. Since the presentprocedure is percutaneous, no initial pre-distraction of the disc spaceis accomplished beyond the amount of distraction that can be obtained byproper positioning of the patient on the Andrews frame.

The injection pressure may be estimated by the amount of manual pressurethat can be achieved with the injection syringe 82. Alternatively, apressure gage may be mounted to the needle hub 78 or stopcock valve 80to provide a visual reading of the injection pressure. It is understoodthat the pressurized IDN material will seek to fill all voids andfissures in the disc nucleus pulposus, but will be contained by the discannulus.

Once the desired amount of IDN material has been injected, the stopcockvalve 80 is closed to maintain the fluid pressure. The injectionassembly 70 is preferably held in place during the minimum cure time,which is about five minutes in the specific embodiment. After theinitial cure period, the injection needle is removed. The natural discand augmenting IDN material will collapse to fill the minimal channelleft by removal of the injection needle 74. The quick curing of thematerial, coupled with its natural adherent properties allow the IDN tosubstantially fully seal the entry point into the disc nucleus. Thepercutaneous nature of the procedure allows the wall of the disc annulusto collapse around the minimal channel left after the docking cannula 72has been removed from the disc.

In a particular practice of the injection step, the injection needle 74may be gradually retracted as the IDN material continues to be injected.Careful and controlled movement of the syringe 82 is necessary to ensurethat the injection needle is retracted only to the inner border of thedisc annulus and maintained in that position during the initial cureperiod. With this practice, the entire disc space is substantiallyfilled, under pressure, with the IDN material.

While the injection assembly 70 has been described herein as includingthe docking cannula 72 and a separate injection needle 74, it should beunderstood that other injection alternatives are contemplated. Forexample, in certain situations where perhaps the surgeon has more timeto inject a curable material than the particular embodiments described,the needle 74 itself may be directly injected without use of the dockingcannula 72.

In an alternative embodiment depicted in FIGS. 21-22, a docking cannula90 may be provided that includes a threaded tip 92. The threads areconfigured to pierce the annulus as the docking cannula 90 is rotated.With this alternative, the hub may be modified from the hub 76 of thecannula 72 to provide a gripping surface suitable for manual threadingof the cannula 90 into the disc annulus. Such threaded cannula 90 wouldprovide a more positive anchoring of the cannula 90 to the annulus. Inaddition, a seal would be provided between the threaded tip 92 and thewall of the annulus since the cannula 90 is threaded into the annuluswithout an annulotomy being performed. As such, it is considered thatsuch a threaded cannula 90 would allow injection of curable biomaterialat pressures greater than 160 psi and potentially up to as high as 200psi. To aid in the insertion of the threaded cannula 90, a thin-walledretractable outer sheath may be positioned over the threads duringinsertion, and withdrawn upon insertion as the threaded tip 92 nears theannulus wall. It should also be understood that as noted above, theneedle itself may be used without an outer cannula, and in such asituation, the needle 74 may be provided with threads at its distal tip.

In a modification of the threaded docking cannula 90, a flange 95 may bedefined on the cannula, as depicted in phantom lines in FIG. 22. Thisflange 95 may act as a stop to control the amount of insertion of thethreaded tip 92 into the disc annulus. The flange may also assist inproviding and maintaining a fluid-tight seal at the opening formed inthe annulus. The flange may also include a fitting, such as a Luer lockfitting, to mate with the hub 78 of the injection needle. In this case,the fitting is preferably sized so that the fitting is accessibleoutside the percutaneous wound in the patient. Such a flanged cannulamay have particular application in the open DDD and/or AMD surgicalprocedures described hereinabove.

In a further modification, a threaded docking cannula 100, depicted inFIGS. 23 a-b, includes an expandable flange 106. The cannula includes acannula body 102 terminating in threads 104 for engagement within thedisc annulus, as with the embodiments described above. The expandableflange 106 is interposed between a fixed collar 108 and a sleeve 110that is slidably disposed about the cannula body 102. The expandableflange is configured to have an un-expanded condition 106, as shown inFIG. 23 a and then to move to an expanded condition 106′, shown in FIG.23 b, upon pressure from the sleeve 110. In a specific embodiment, theflange 106 is formed of a resilient material that deforms when pressedby the sleeve but returns substantially to its un-expended condition(FIG. 23 a) when the pressure is removed. In its un-expanded condition,the flange 106 has a small enough outer profile or diameter to be usedpercutaneously.

As set forth above, in the percutaneous procedure for treating the DDDcondition, a discogram is described as pre-operatively testing integrityof the disc annulus to determine if the disc is competent for subsequentdirect injection of biomaterial under relatively high pressures of about100 psi or more. If the discogram is negative, such direct injection istypically contraindicated. The following dual injection procedure may beconsidered as an alternative treatment in such situation, where theannulus is still relatively intact.

In a first step of this alternative, dual injection method, a firstsuitable quantity of IDN is prepared as described above and injectedinto the nucleus pulposus using, for example, the injection needleassembly 70 illustrated in FIGS. 19-20. The material is injected atrelatively low pressure, i.e., on the order of about 25-40 psi,sufficient to allow the material to flow through and fill any fissuresin the nucleus pulposus, but without causing distraction. The IDNmaterial is allowed to cure as described above, thereby providing a sealinteriorly of the annulus within the disc space. In the second step, asecond suitable quantity of IDN is prepared and injected through thesame access as the first injection, again using, for example aninjection needle assembly 70. The second quantity of IDN is injectedunder relatively high pressure, on the order of at least 100 psi inorder to substantially fill the disc space and distract the opposingvertebral bodies, the first cured quantity of IDN serving as a barrierto maintain the second pressured quantity of IDN with the disc space.

It should also be appreciated that a kit of the components describedherein may be provided to a surgeon in order to perform the surgicalprocedures described herein. Thus, a kit may include, but not be limitedto, a vented needle or needle assembly, a suitable quantity of IDNmaterial or its constituent parts to be mixed, a mixer for mixing theconstituent parts, and a suitable syringe.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same should be considered asillustrative and not restrictive in character. For example, while theinjection assembly having either the smooth or the threaded cannula hasbeen described as having particular application in a high pressure,percutaneous procedure, it should be appreciated that such an injectionneedle assembly may also be used in applications where distraction andhigh pressures are not warranted. It is understood that only thepreferred embodiments have been presented and that all changes,modifications and further applications that come within the spirit ofthe invention are desired to be protected.

1. A method for treating a diseased or damaged intervertebral spinaldisc having an inner nucleus pulposus and an outer annulus, comprisingthe steps of: providing access to the nucleus pulposus through theannulus; removing at least a portion of said nucleus pulposus to createan intradiscal space; determining the integrity of said annulus; andthen sealably introducing under pressure a curable biomaterial throughsaid annulus access directly into said intradiscal space.
 2. The methodof claim 1, wherein said access is provided by an extraforaminalapproach to the disc.
 3. The method of claim 2, wherein saidextraforaminal approach is selected from the group of surgical entriesconsisting of a lateral retroperitoneal approach and a paramedianapproach through the paraspinal muscles.
 4. The method of claim 1,wherein said access is an opening extending through the annulus.
 5. Themethod of claim 4, wherein said opening is a rupture through saidannulus resulting from a herniation.
 6. The method of claim 4, whereinthe opening is formed by an annulotomy.
 7. The method of claim 6,wherein an annulotomy creating a cruciate form is performed.
 8. Themethod of claim 4, wherein the integrity of said annulus is determinedby introducing a fluid into said disc through the annulus opening and atleast into the intradiscal space.
 9. The method of claim 8, wherein saidfluid is a saline solution injected under pressure through a needle. 10.The method of claim 9, wherein said saline solution is sealably injectedthrough said opening into said disc.
 11. The method of claim 10, furtherincluding the step of providing a seal for said annulus opening duringthe injection of said saline solution.
 12. The method of claim 11,further including the step of providing a vent through said seal forventing said intradiscal space.
 13. The method of claim 11, wherein saidseal is provided on said needle.
 14. The method of claim 11, whereinsaid seal comprises a compressible portion, said seal being compressiblypressed against the exterior surface of said annulus adjacent saidopening during injection of said saline solution.
 15. The method ofclaim 14, wherein said seal is pressed manually against said annulus.16. The method of claim 10, wherein said saline solution is injected ata pressure within the range of about 25-40 psi.
 17. The method of claim9, wherein said saline solution is substantially removed before saidbiomaterial is introduced.
 18. The method of claim 1, further includingthe step of determining the approximate amount of biomaterial to beintroduced.
 19. The method of claim 10, wherein the approximate amountof biomaterial to be introduced is determined by measuring the amount ofsaline solution injected into said disc.
 20. The method of claim 19,wherein the biomaterial is sealably injected through a needle at apressure not greater than the pressure at which said saline solution isinjected.
 21. A method for treating a diseased or damaged intervertebralspinal disc having an inner nucleus pulposus and an outer annulus,comprising the steps of: providing access to the nucleus pulposusthrough the annulus; removing at least a portion of said nucleuspulposus to create an intradiscal space; sealably introducing into saiddisc through said opening a fluid solution under a first pressure todetermine the integrity of said annulus; and then sealably introducingunder a second pressure a curable biomaterial through said annulusdirectly into said intradiscal space.
 22. The method of claim 21,wherein said fluid solution is a saline solution.
 23. The method ofclaim 21, wherein said fluid solution is injected into said disc througha sealed needle.
 24. The method of claim 23, further compressing a ventin communication with said intradiscal space for venting salinesolution.
 25. The method of claim 21, wherein said biomaterial isinjected into said intradiscal space through a sealed needle.
 26. Themethod of claim 25, further comprising a vent in communication with saidintradiscal space for venting biomaterial.
 27. The method of claim 21,wherein said second pressure under which said biomaterial is introducedis not greater than the first pressure under which said fluid solutionis introduced.
 28. The method of claim 21, wherein said second pressureunder which said biomaterial is introduced is increased or decreasedrelative to said first pressure in relation to the viscosity of saidbiomaterial relative to the viscosity of said fluid solution.
 29. Themethod of claim 21, wherein said method is practiced in the treatment ofa herniated disc and wherein said access is defined by a rupture throughsaid annulus.
 30. The method of claim 21, wherein said method ispracticed in the treatment of degenerative disc disease, and whereinsaid access is an opening created through said annulus by an annulotomy.31. A method for treating a diseased or damaged intervertebral spinaldisc between opposing vertebral bodies having an inner nucleus pulposusand an outer annulus, comprising the steps of: providing access to thenucleus pulposus through the annulus; removing at least a portion of thenucleus pulposus to create an intradiscal space; applying a force todistract the opposing vertebral bodies about the intradiscal space;determining the integrity of said annulus, and then sealably introducingunder pressure a curable biomaterial through said annulus accessdirectly into said intradiscal space.
 32. The method of claim 31,wherein said access is an opening extending through said annulus. 33.The method of claim 32, wherein said distraction force is applied byinserting an expandable device through said opening in an un-expandedcondition and expanding said expandable device within said intradiscalspace.
 34. The method of claim 33, wherein said expandable device is aninflatable non-compliant balloon.
 35. The method of claim 34, furtherincluding the step of removing the balloon from the intradiscal space.36. The method of claim 32, further including the step of determiningthe size of said intradiscal space.
 37. The method of claim 36, whereinsaid step of determining the size of said intradiscal space is practicedby expanding an inflatable device within said intradiscal space.
 38. Themethod of claim 37, wherein said inflatable device is a compliantballoon inserted into said intradiscal space in a deflated condition andinflated within said intradiscal space until it stops against the farborder of said intradiscal space.
 39. The method of claim 38, whereinsaid compliant balloon is filled with a contrast medium capable ofvisualization under fluoroscopy.
 40. The method of claim 36, wherein theintegrity of said annulus is determined by introducing a saline solutioninto said disc through the annulus opening and at least into theintroduced space.
 41. The method of claim 40, wherein said salinesolution is sealably injected through said opening into said discthrough a needle under pressure.
 42. The method of claim 41, wherein aseal is provided on said needle.
 43. The method of claim 42, furtherincluding the step of providing a vent through said seal for ventingsaid intradiscal space.
 44. The method of claim 31, wherein saiddistraction force is removed prior to the step of introducing saidbiomaterial into said intradiscal space.
 45. The method of claim 31,wherein said distraction force is applied on the vertebral bodiesexternally of the intradiscal space.
 46. The method of claim 45, whereinsaid external distraction force is maintained during the step ofintroducing said biomaterial into said intradiscal space.